FDA Webview

Free FDA Notices

Pilot Project for Drug REMS in SPL Format


Federal Register Notice: FDA is announcing a pilot project for submitting final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. Its purpose is to help participants and FDA evaluate the potential of converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. Requests to participate in pilot should be submitted 10/6-12/7. To view this notice, click here.